TERM - Sr Manufacturing Associate

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Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Job Summary - TERM The Sr Manufacturing Associate role supports the filling of specialty pharmaceutical products and the manufacturing of medical device components which directly contributes to our mission of protecting and enhancing life.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Responsibilities   Lives our culture of “right the first time” and ensures quality and accuracy in day-to-day activities
Executes and documents procedural steps in compliance with current Good Manufacturing Practices (cGMP) standards and other regulatory requirements
Escalates problems, concerns, or deviations in a timely manner
Maintain production areas in a tidy, 6 sigma (6S) standard including cleaning and sanitization of work areas
Identifies and communicates process improvement and operational excellence initiatives
Exercises judgment within defined procedures and practices to determine appropriate action
Ability to train others
Work in confined spaces
Aseptic Filling   Independently prepare and sterilize equipment
Independently setup and run the SA25 filler for product filling operations
Troubleshooting issues at Engineering user level
Run all viable and non-viable samples and independently process samples through the local and LIMS system
Perform product transfer and sterile filtration
Manufacturing Medical Device Components (RSDL / ISDTL)  Execute detailed manual and high impact process tasks requiring extensive documentation and interface with automated controls. Process operation involves manual assembly, cleaning, and connections to lobe pumps, nitrogen supply lines, 600 kg inline pressure tank, 500 kg and 2900 kg kettles. Monitoring/adjustment of vessel temperatures, mixer speeds, and nitrogen flow rates during execution to maintain the operational environment.
Clean large lobe pump, hose lines, mesh screen assembly, 500 kg and 2900 kg kettles, and small parts (clamps, regulators, gasket, etc.)
Operate valves, temperature settings, and mixing speed controls using Delta V operating systems
Perform in process sampling for PH, conductivity, and finale product samples and work with LIMS system to receive and submit samples
Move materials which can weigh more than 36 kgs
Work with large and small scales to perform in process dispensing activities.
Repeatedly lifting, moving, and adding chemicals to the kettles while wearing required PPE (i.e. half mask respirator)
Maintain a state of full gowning (scrubs, mask, safety glasses/goggles, gown, boot covers, gloves, and respirator) for multiple hours at a time.
Follow established cleanroom behaviors
Extended time periods of standing, climbing, and bending
Working at elevated heights
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills   High school Diploma or equivalent is required;
Pharmaceutical manufacturing diploma or Bachelors’ degree in Science / Engineering is considered an asset
Minimum of 3 years of related experience is required;
Previous experience working in a regulated environment is required
Ability to read, understand, and follow standard operating procedures, protocols, work instructions, and other policies/procedures is required
Strong written and verbal communication skills
Ability to work in a group environment
Strong accuracy and…